Phase II randomized trial comparing 5-fluorouracil in continuous infusion and cisplatin (FP) versus leucovorin, bolus 5-fluorouracil and cisplatin (FLP) in metastatic gastric, pancreatic and oesophageal cancer
| ISRCTN | ISRCTN05842222 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05842222 |
| Protocol serial number | FFCD 9404 trial |
| Sponsor | French Federation of Digestive Cancers (Fédération Francophone de la Cancérologie Digestive [FFCD]) (France) |
| Funder | Lederle F93/LFOL/02 |
- Submission date
- 01/09/2005
- Registration date
- 06/09/2005
- Last edited
- 24/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Marc Ychou
Scientific
Scientific
CRLC Val d'Aurelle
Parc Euromédecine
Montpellier
34298
France
| MYchou@valdorel.fnclcc.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | FFCD 9404 |
| Study objectives | Compare the safety (primary objective) and clinical efficacy and quality of life (secondary objectives) of FLP versus FP as a first line chemotherapy in patients with metastatic gastric, pancreatic and oesophageal cancer |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Metastatic gastric, pancreatic and oesophageal cancer |
| Intervention | First line chemotherapy - 5-fluorouracil in continuous infusion and cisplatin (FP) versus leucovorin, bolus 5-fluorouracil and cisplatin (FLP) |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil and cisplatin (FP) and leucovorin, bolus 5-fluorouracil and cisplatin (FLP) |
| Primary outcome measure(s) |
Safety |
| Key secondary outcome measure(s) |
Clinical efficacy and quality of life |
| Completion date | 01/05/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 232 |
| Key inclusion criteria | Histologically proven carcinoma of the oesophagus, the stomach or the pancreas, with a measurable metastatic disease (≤15 mm) and without indication of radiotherapy and/or surgery; no prior chemotherapy for metastatic disease and, in case of adjuvant chemotherapy, no regimen containing cisplatin; age ≤75 years and World Health Organization (WHO) performance status <2; adequate baseline organ function, defined as neutrophile count ≥1500/mm^3, platelet count ≥100,000/mm^3 and creatinine level <1.25 normal level; in case of patient older than 70 years and/or creatinine level between 1 and 1.25 normal limit, creatinine clearance had to be more than 60 ml/mm; and written informed consent approved by the local Ethical Committee was given by all the participants before they entered the study. |
| Key exclusion criteria | Severe uncontrolled co-morbidities, brain metastases |
| Date of first enrolment | 01/04/1995 |
| Date of final enrolment | 01/05/1997 |
Locations
Countries of recruitment
- France
Study participating centre
CRLC Val d'Aurelle
Montpellier
34298
France
34298
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2006 | Yes | No |
